LENSAR Inc., developer of the LENSAR Laser System™ for
cataract surgery, today provided an update on the company’s recent
regulatory and commercialization efforts for its novel laser cataract
surgery system. The LENSAR Laser System represents the latest scientific
breakthrough in cataract surgery, combining the most advanced laser
technology with unique product features specifically intended to meet
the advancing needs of refractive cataract surgeons to enhance their
patients’ outcomes. Recent developments include:

Regulatory:

In recent months, LENSAR has received 510(k) clearance from the United
States Food and Drug Administration and CE Mark approval from European
regulators for the LENSAR Laser System. Both regulatory actions, which
cover the use of the novel platform in capsulotomy with and without
laser phacofragmentation during cataract surgery, have opened the door
for strategic and aggressive commercialization efforts in these markets.

Commercialization:

Following recent regulatory approvals secured in multiple regions
throughout the world, LENSAR has already shipped over 20 LENSAR Laser
Systems to cataract surgeons in 11 countries. In the U.S., the company
announced in July that the first laser cataract surgeries using the
platform were successfully completed by two of the country’s leading
cataract surgeons. Interest in the system continues to grow rapidly
among cataract surgeons across the country and multiple additional
system placements confirm the high performance and ease of use. In
Europe, the company has generated significant demand for the LENSAR
Laser System and has shipped several of its systems to cataract surgeons
in various European countries. LENSAR continues to work with Topcon
Europe Medical BV, its distribution and marketing partner in Europe, to
generate and service the growing demand for its platform.

Technology Highlights:

As part of its broad commercialization efforts, LENSAR showcased the
LENSAR Laser Systems’ next generation differentiating Augmented Reality
imaging technology to attendees at the recent annual meeting of the
American Academy of Ophthalmology (AAO). This breakthrough platform
consists of proprietary high-resolution 3D-imaging measurement
technology, allowing imaging and precise biometric measurements of the
anterior segment eye anatomy regardless of cataract density. Unlike
traditional imaging systems, LENSAR’s Augmented Reality platform
provides clean, low noise images that are both high contrast and high
resolution from the anterior surface of the cornea to the posterior
capsule of the crystalline lens, while automating the ability to correct
for lens tilt or centration during the customized treatment to
accommodate each patient’s individual anatomy. In addition, this
technology allows the creation of the precise capsulotomy incision size,
shape, and location, enhancing effective IOL lens positioning and
fitting for each individual patient, leading to optimized patient
outcomes.

Importantly, the system’s sophisticated phacofragmentation techniques
allow for easier and more efficient removal of all grades of cataracts
and a major reduction in, or in a large number of procedures complete
elimination of the use of the ultrasound energy required in conventional
cataract surgery. Furthermore, the entire procedure can take place in a
single procedure room and the mobile LENSAR Laser System is easily
adaptable to existing surgical facilities, allowing surgeons a never
before available level of precision, efficiency, patient comfort, and
safety.

“Our deliberate regulatory and commercialization strategy for the LENSAR
Laser System has successfully generated tremendous interest from
refractive cataract surgeons in the U.S., Europe and other international
markets,” said Nick Curtis, LENSAR’s Chief Executive Officer. “We are
pleased by the significant worldwide demand for our system as it
demonstrates that physicians are recognizing the value of the platform’s
important competitive advantages in the area of its superior imaging and
measurement technology, treatment efficiency, reduced ultrasound
requirements and ergonomics. These features combine to facilitate
surgeons being able to achieve their ultimate goal for each of their
patients.”

“Following a strategic introduction of the LENSAR system in the U.S.,
including the successful installations in several high volume cataract
practices, we are excited by the momentum also being generated for this
breakthrough product in the broader international cataract surgeon
community,” said Steve Elms, Managing Partner at Aisling Capital and
Chairman of the Board of LENSAR. “It is gratifying to be able to support
a company such as LENSAR that is able to conceive, develop,
commercialize and then successfully launch a novel technology that
possesses the ability to dramatically impact the lives of so many
patients.”

About LENSAR, Inc.

LENSAR, Inc. is a leader in the development and commercialization of a
next generation laser and advanced 3D imaging technology for refractive
cataract surgery. For more information please visit www.lensar.com

LENSAR™ Laser System has been cleared by FDA for anterior
capsulotomy and lens fragmentation. For other indications it is an
investigational device limited by US law to investigational use only.
The system has been used in about 2000 eyes in and outside the US to
date.

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